Article
A Phase I Open-Label Study to Identify a Dosing Regimen of the Pan-AKT Inhibitor AZD5363 for Evaluation in Solid Tumors and in PIK3CA-Mutated Breast and Gynecologic Cancers.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 May 2018
Banerji Udai, Dean Emma J, Pérez-Fidalgo J Alejandro, Batist Gerald, Bedard Philippe L, You Benoit, Westin Shannon N, Kabos Peter, Garrett Michelle D, Tall Mathew, Ambrose Helen, Barrett J Carl, Carr T Hedley, Cheung S Y Amy, Corcoran Claire, Cullberg Marie, Davies Barry R, de Bruin Elza C, Elvin Paul, Foxley Andrew, Lawrence Peter, Lindemann Justin P O, Maudsley Rhiannon, Pass Martin, Rowlands Vicky, Rugman Paul, Schiavon Gaia, Yates James, Schellens Jan H M
Abstract excerpt
Purpose: This phase I, open-label study (Study 1, D3610C00001; NCT01226316) was the first-in-human evaluation of oral AZD5363, a selective pan-AKT inhibitor, in patients with advanced solid malignancies. The objectives were to investigate the safety, tolerability, and pharmacokinetics of AZD5363, define a recommended dosing schedule, and evaluate preliminary clinical activity.Experimental Design: Patients were...
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